MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS PROGRIP; MESH, SURGICAL, POLYMERIC

Model Number TEM1515G

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Abscess (1690); Purulent Discharge (1812); Fever (1858); Hematoma (1884); Inflammation (1932); Seroma (2069); Discharge (2225); Injury (2348); Impaired Healing (2378); Ascites (2596); Blood Loss (2597); No Code Available (3191); Thrombosis/Thrombus (4440)

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of a ventral hernia.It was reported that after the onlay implant, the patient experienced fluid collection, fever, abdominal pain, cloudy drainage, purulent material, non-healing wound, bleeding, blood clots, hematoma, draining sinus tract, induration, inflammation, abscess, and mesh plugged up the abdominal wound and formed a dense seroma cavity.Post-operative patient treatment included revision surgery, debridement of skin/subcutaneous tissue/abdominal wound, mesh removal, drain placed, wound vac, evacuation of hematoma, suture ligation of bleeding vessel, excision of sinus tract, indurated/inflamed tissue removed, and excision of abdominal wall seroma cavity.

• Brand Name: PROGRIP
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• Manufacturer (Section G): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• Manufacturer Contact: lisa hernandez ; 60 middletown ave; north haven, CT 06473 ; 2034925563
• MDR Report Key: 10639593
• MDR Text Key: 210170581
• Report Number: 9615742-2020-02296
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521177727
• UDI-Public: 10884521177727
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2018
• Device Model Number: TEM1515G
• Device Catalogue Number: TEM1515G
• Device Lot Number: SNC0050
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/16/2020
• Date Device Manufactured: 03/20/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 113